Device Description Product Overview

Surgical Technique Guide

UDM

I

Device Description .............................................................. II

Surgical Overview ............................................................ IV

Product Overview .............................................................. VI

Surgical Protocol

Preoperative Planning and Templating ...................................1

A. Acetabular Reaming .........................................................2

B. Cup Trialing .......................................................................4

C. Cup Positioning.................................................................6

D. Cup Impaction ................................................................ 11

E. Trial Reduction ................................................................12

F. Mobile Liner & Femoral Head Assembling .....................13

G. Final Reduction ...............................................................15

Appendix ..............................................................................16

Order Information ..............................................................22

Table of Contents

United Orthopedic UDM

II III

UDM –

The United Dual Mobility (UDM) Acetabular System is applied in a primary or revision total hip arthroplasty for acetabulum reconstruction. Based on two classic concepts, Sir Charnley’s low friction principle and the anti-dislocation theory by using larger femoral head diameter, the cobalt-chrome alloy-based UDM Acetabular System provides greater range of motion and superior jumping distance to reduce the risk of component impingement and joint dislocation. The advanced TPS PLUS/TPS PLUS with HA surface coating for cementless cup options contribute sufficient initial stability and enhances long-term osteointegration, while the classic discharge grooves design for cemented cup option promotes even cement distribution and implant stability. Various implant types are provided for fulfilling clinical demand: UDM cups:● Press-fit cup● Peg-fixed cup● Cemented cup

Mobile liner materials:● XPE (Highly Crosslinked Polyethylene)● E-XPE (Vitamin E Highly Crosslinked Polyethylene)

DeviceDescription

INDICATIONS

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.

2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve

satisfactory results.4. Correction of functional deformity.5. Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is

unmanageable using other techniques. The device is intended for cementless use except the cemented dual mobility cup is for cemented use only.

Please refer to the package inserts for important product information, including, but not limited to contraindications, warnings, precautions, and adverse effects.


IV V

Surgical Overview

A. Acetabular Reaming B. Cup Trialing C. Cup Positioning D. Cup Impaction

E. Trial Reduction F. Mobile Liner & Femoral Head Assembling

G. Final Reduction


VI 1

The reconstruction of hip anatomy and restoration of joint biomechanics are the main objectives in restoring joint function through total hip replacement. A comprehensive analysis of the affected hip is needed. Anteroposterior (A/P) and lateral roentgenographic images are crucial to help determining hip rotational center and correcting component size. An A/P roentgenographic image of the pelvis may be necessary to verify preoperative decisions by comparing with the contralateral side.

Templating the outline of the component which best fits the acetabulum is recommended, thus an ideal implant position and a correct sizing can be achieved. The template of acetabular cup should be positioned towards the medial aspect of the acetabulum as possible, simultaneously, the appropriate center of rotation is important to consider in restoring optimal hip biomechanics.

Please note the UDM system is a concentric design. Care should be taken to avoid overlap between the component and the teardrop, any uncovering of the component, and inclination over 45°. However, the final determination should be made depending on the actual condition and patient's needs during surgery.

Preoperative Planningand Templating

Product Overview

Mobile Liner

Femoral Head

XPE Mobile Liner

Press-fit DM Cup Peg-fixed DM Cup Cemented DM Cup

Dual Mobility Acetabular Cup

CoCr alloyFemoral Head

BIOLOX® deltaFemoral Head

E-XPE Mobile Liner

Note: The compatibility of UDM cup and mobile liner are restricted in certain area, please contact with your United representative or local distributor for further information.


2 3

Appropriate reaming of the acetabulum is important for the cup to be fully seated within. It is important to understand that the labeled size on the Dual Mobility instrumentation is an nominal dimension. All articular cartilage, osteophytes, and any soft tissues should be removed throughout the reaming process.

Hold the Cup Reamer Handle at an abduction of 40°- 45° and an anteversion of 15°-20°. Utilize the smallest Cup Reamer to begin acetabular reaming, then gradually proceed with enlarged reamers in 1-2 mm increments until the planned size is achieved.

Press-fit and Peg-fixed DM CupThe implant with TPS PLUS type has 0.35 mm surface coating thickness on each side. For example, a 58 mm cup of TPS PLUS type represents a 58.7 mm at the outer diameter.

The under reaming of the cavity by 1 mm is recommended. Sometimes a line-to-line reaming would be required to treat an acetabulum with high bone density.

Cemented DM CupA 2 mm cement mantle thickness is recommended for centralizing the component and providing sufficient holding strength.

Acetabular Reaming Acetabular Reaming

Instruments

A. A.

Cup Reamer Handle Cup Reamer

A 58 mm reamer reams for a 58 mm cup

A 58 mm reamer reams for a 58 mm cup

A 58 mm cup trial is 58 mm in diameter

A 58 mm cup trial is 58 mm in diameter

A 58 mm cup is 58.7 mm in diameter with coating

A 54 mm cement cup is recommended for 2 mm cement mantle thickness


4 5

A trial of the same size as the reamer allows assessment of the fit and position of the cup. Key characteristics of the cup trial are as follows :

A Notch shows the position of the flange for the Peg-fixed DM Cup.

B Two holes indicate the position of the pegs for Peg-fixed DM Cup.

C The extended 3 mm rim represented as the implant for directional confirmation.

Connect the Cup Trial Handle and the DM Cup Trial with the selected size. Place the trial into the reamed acetabulum to check the congruency between the bone and trial and also to confirm stability. If a Peg-fixed DM cup is utilized, the notch on the rim of DM Cup Trial indicates the location where the flange will be placed. Mark the direction of the flange as needed.

Cup Trialing Cup Trialing

Instruments Instruments

B. B.

Cup Trial HandleDM Cup Trial DM Cup Trial

Note: If a Cemented DM Cup is desired, the cup diameter will be 4 mm lesser than the DM

Cup Trial due to preserved 2 mm circumferential cement mantle thickness. For example, if a 58 mm DM Cup Trial is applied for confirmation, the 54 mm Cemented DM Cup implant should be selected for final implantation.

A

A C

B B


6 7

The size specific Cup Holder Adaptors allow the cup trial or final implant to be held securely. Its characteristics are as follows:

Open the lever of the Cup Positioner to the unlocked position. Then, assemble the Cup Holder Adaptor to the Cup Positioner. The size of the Cup Holder Adaptor should be consistent with the designated cup size.

Instruments

Straight Cup Positioner Cup Holder AdaptorOffset Cup Positioner

①

②

▲

▲

▲

Cup Positioning Cup PositioningC. C.

A Notch designed to be aligned to the laser mark on the rim of the DM Cup.

B The apex of the triangular size helps align with the laser mark on the rim of the cup.

C The mark on the adaptor indicates the correct orientation for the adaptor.

AA

A

CB

B

B

The United DM Cup provides Offset Cup Positioner to accommodate anterior hip approaches and MIS approaches. It is used to hold and to position the implant. An optional Holder Shaft indicates the vertical axis or 45° angle compared to the cup face.

Unlocked position for placing the size specific

cup holder adaptorNeutral position

Locked position securely grips the cup trial or

final implant for insertion

C

C

Note: The tip of triangular marks on both instruments

should orient towards each other.


8 9

Mount the selected cup to the Cup Holder Adaptor. To confirm correct orientation of the cup, ensure the notch, laser marks, and the apex of the triangular size indicator on the Cup Holder Adaptor align with the laser mark on the rim of the cup. Lock the Cup Positioner so that the cup can be tightly held.

Instruments

Straight Cup Positioner Cup Holder AdaptorOffset Cup Positioner

Cup PositioningC.Before inserting the cup, assemble the Holder Shaft onto the Offset Cup Positioner for alignment reference and handling. A 45° inclination is recommended for general cup orientation.

Instruments

Straight CupPositioner

Alignment Tower, Lateral

Cup Holder Adaptor Holder ShaftOffset CupPositioner

Alignment Rod

45˚

Cup PositioningC.

Note: If a Straight Cup Positioner is utilized, the Alignment Tower and Alignment Rod

can be set on the positioner as a reference.


10 11

Insert the selected cup, position as outlined above, and proceed with impaction. Once the cup is in the optimal position and full seated, unlock the Cup Positioner to release the cup. Remove the Cup Positioner and Cup Holder Adaptor from the cup implant.

Instruments

Note: Impingement of iliopsoas muscle at the anteromedial region must be avoided. In general,

the most extruded rim/flange should be located towards the posterosuperior region to provide greater jumping distance for the mobile liner without causing serious soft tissue impingement.

Cup PositioningC.Connect the Universal Handle to the Final Cup Impactor. Use the blunt end to impact the cup until fully seated.

If a Peg-fixed and Cemented DM cup is applied, please refer to the Appendix for guidance.

Instruments

Universal Handle Final Cup Impactor

Cup ImpactionD.


Alignment Tower, Lateral

Cup Holder Adaptor Holder ShaftOffset CupPositioner

Alignment Rod


12 13

Trial Reduction

Instruments

E.Place the Mobile Liner Trial with the selected head trial, then perform a trial reduction to check the mobility and stability of the structure.

The Green Mobile Liner Trial are used with head trials of Ø 28 mm. To carry out trialing with Ø 22 mm heads, it is necessary to combine the Green Mobile Liner Trial and Mobile Liner Trial Adaptor, 28/22.

Mobile Liner TrialMobile Liner Trial Mobile Liner Trial Adaptor, 28/22

Mobile Liner Trial(42-44 mm)

Normal :DM Press Handle

Option :

Mobile Liner Trial Adaptor, 28/22

Head Trial(28 mm)

Head Trial(22 mm)

Head Trial(22 mm)



Assemble the DM Press, DM Liner Holder, and Press Baseplate as following steps.Fix the DM Press Handle to the Press Baseplate, then screw the DM Liner Holder onto the Press Baseplate.

Mobile Liner & Femoral Head Assembling

Instruments

F.

DM Press Press Baseplate DM Liner Holder

①②

Place the selected mobile liner onto the DM Liner Holder, then place the femoral head over the entrance of the mobile liner.

③


14 15

Mobile Liner & Femoral Head Assembling

F.

⑤

⑥

④

Engage the final liner/head structure to the trunnion of the femoral stem. Connect the Universal Handle to the Liner Head Impactor and impact the liner/head structure against the trunnion. Clean the articulating surface of the cup and finish the reduction. Check the range of motion and joint stability again before closing the incision.

Final Reduction

Instruments

G.

Universal Handle Liner Head Impactor

Pull the collar on the DM Press Handle to seat the body onto the femoral head.

Rotate the press handle clockwise until the femoral head is forced into the mobile liner.

During assembly of the liner onto the head, the user will feel resistance increase twice and hear two noises as the head passes the retentive bore and then air escapes from the bearing.

Correct assembly is confirmed when the femoral head rotates freely in the mobile liner.


16 17

Peg-fixed DM CupA. Flange BendingThe flange on the Peg-fixed DM Cup is pre-bent. The angle and curvature of the flange can be adjusted by using the Flange Bender to further bend the flange for improving anatomical fit.

Appendix

Instruments

Flange Bender

B. Peg Space PreparationUse the Flexible Peg Drill to create the pilot holes through the Peg Drill Guide. Then, use Peg Dilator to create the space for pegs.

Appendix

Instruments

Flexible Peg Drill Curved Peg DilatorPeg Drill Guide Offset Peg Dilator


18 19

C. Peg InsertionAttach the peg onto the Peg Inserter, insert into the peg holes on the cup, then moderately impact the peg into the peg hole. Fully impact the peg ensuring the peg is fully seated. Confirm the no eminence of peg from the articulating surface of the cup. Then, continue with the second peg preparation.

Appendix

Instruments

Curved Peg Inserter Offset Peg Inserter

Note: Check that the pegs do not stand proud from the inner surface of the cup.

D. Screw FixationPlace the DM Flange Drill Guide into the screw hole on the flange, and drill through the guide using the Drill, 3.2 mm. The recommended drilling depth is to the inner edge of the second cortex. Measure the required length of screw using the Depth Gauge, then insert the selected cobalt-chrome cortical screw by using the Screwdriver with Ratchet Handle. Tightly secure the screw to accomplish the fixation of peg-fixed DM cup.

Appendix

Instruments

DM Flange Drill Guide Straight ScrewdriverDrill, 3.2 mm Ratchet HandleDepth Gauge


20 21

E. Peg RemovalExtract the cobalt-chrome cortical screw by using the Screwdriver with Ratchet Handle. Screw the Peg Remover into the thread inside the peg through the Peg Remover Guide ,then the Peg Remover will pull the peg out.

Repeat for the second peg.

Appendix

Instruments

Straight Screwdriver Peg Remover GuideRatchet Handle Peg Remover

Cemented DM CupPrepare cement to the desired level of viscosity. Put the cement into the reamed acetabulum and onto the backside of the cemented cup. Place the cup into acetabulum and remove the redundant cement. Note a 2 mm cement mantle is recommended for centralizing the component and providing sufficient holding strength. Hold the Cup Positioner in position until the cement is fully set. Disengage the Cup Positioner and the Cup Holder Adaptor.

Appendix

Instruments


Cup Holder AdaptorOffset CupPositioner

22 23

Order Information Catalog Number Description

1307 - 12421307 - 12441307 - 12461307 - 12481307 - 12501307 - 12521307 - 12541307 - 12561307 - 12581307 - 12601307 - 12621307 - 12641307 - 12661307 - 1268

1307 - 52421307 - 52441307 - 52461307 - 52481307 - 52501307 - 52521307 - 52541307 - 52561307 - 52581307 - 52601307 - 52621307 - 52641307 - 52661307 - 5268

1307 - 30421307 - 30441307 - 30461307 - 30481307 - 30501307 - 30521307 - 30541307 - 30561307 - 30581307 - 30601307 - 30621307 - 3064

5107 - 10255107 - 10305107 - 10355107 - 10405107 - 10455107 - 10505107 - 10555107 - 10605107 - 1065

1307 - 10421307 - 10441307 - 10461307 - 10481307 - 10501307 - 10521307 - 10541307 - 10561307 - 10581307 - 10601307 - 10621307 - 10641307 - 10661307 - 1068

1307 - 50421307 - 50441307 - 50461307 - 50481307 - 50501307 - 50521307 - 50541307 - 50561307 - 50581307 - 50601307 - 50621307 - 50641307 - 50661307 - 5068

OD 42 mmOD 44 mmOD 46 mmOD 48 mmOD 50 mmOD 52 mmOD 54 mmOD 56 mmOD 58 mmOD 60 mmOD 62 mmOD 64 mmOD 66 mmOD 68 mm

OD 42 mmOD 44 mmOD 46 mmOD 48 mmOD 50 mmOD 52 mmOD 54 mmOD 56 mmOD 58 mmOD 60 mmOD 62 mmOD 64 mmOD 66 mmOD 68 mm

OD 42 mmOD 44 mmOD 46 mmOD 48 mmOD 50 mmOD 52 mmOD 54 mmOD 56 mmOD 58 mmOD 60 mmOD 62 mmOD 64 mm

Ø4.5 × 25 mmØ4.5 × 30 mmØ4.5 × 35 mmØ4.5 × 40 mmØ4.5 × 45 mmØ4.5 × 50 mmØ4.5 × 55 mmØ4.5 × 60 mmØ4.5 × 65 mm

Press-fit cup

Peg-fixed Cup

Cemented Cup

Cobalt-chrome Cortical Screw

TPS PLUS

TPS PLUS

TPS PLUS with HA

TPS PLUS with HA

TPS PLUS

TPS PLUS

TPS PLUS with HA

TPS PLUS with HA

Special Order Items

Order Information Catalog Number Description

1207 - 14421207 - 14441207 - 14461207 - 14481207 - 14501207 - 14521207 - 14541207 - 14561207 - 14581207 - 14601207 - 14621207 - 14641207 - 16461207 - 16481207 - 16501207 - 16521207 - 16541207 - 16561207 - 16581207 - 16601207 - 16621207 - 1664

1206 - 11221206 - 13221206 - 15221206 - 17221201 - 10281201 - 11281201 - 12281201 - 14281201 - 16281201 - 1828

1203 - 50281203 - 52281203 - 5428

1207 - 34421207 - 34441207 - 34461207 - 34481207 - 34501207 - 34521207 - 34541207 - 34561207 - 34581207 - 34601207 - 34621207 - 34641207 - 36461207 - 36481207 - 36501207 - 36521207 - 36541207 - 36561207 - 36581207 - 36601207 - 36621207 - 3664

OD 42 mm, ID 22 mmOD 44 mm, ID 22 mmOD 46 mm, ID 22 mmOD 48 mm, ID 22 mmOD 50 mm, ID 22 mmOD 52 mm, ID 22 mmOD 54 mm, ID 22 mmOD 56 mm, ID 22 mmOD 58 mm, ID 22 mmOD 60 mm, ID 22 mmOD 62 mm, ID 22 mmOD 64~68 mm, ID 22 mmOD 46 mm, ID 28 mmOD 48 mm, ID 28 mmOD 50 mm, ID 28 mmOD 52 mm, ID 28 mmOD 54 mm, ID 28 mmOD 56 mm, ID 28 mmOD 58 mm, ID 28 mmOD 60 mm, ID 28 mmOD 62 mm, ID 28 mmOD 64~68 mm, ID 28 mm

* Ø22 mm, +0 mm* Ø22 mm, +3 mm* Ø22 mm, +6 mm* Ø22 mm, +9 mm Ø28 mm, -3 mm Ø28 mm, +0 mm Ø28 mm, +2.5 mm Ø28 mm, +5 mm Ø28 mm, +7.5 mm Ø28 mm, +10 mm

Ø28 mm, S -2.5 mmØ28 mm, M +1 mmØ28 mm, L +4 mm

Mobile Liner

U2 Femoral Head

XPE E-XPE

XPE E-XPE

BIOLOX® deltaFemoral Head

*BIOLOX® is a registered trademark of the CeramTec Group, Germany

* The actual spherical diameter of a 22 mm metal head is 22.2 mm.

Special Order Items

© 2021 United Orthopedic Corporation. UOC-UM-UN-00036 Rev.0 JUN.2021

Please note that this Surgical Technique Guide has been authored in the English language. Any translations into other languages have not been reviewed or approved by United Orthopedic Corporation and their accuracy cannot be confirmed. Any translated guide should be reviewed carefully prior to use and questions regarding a Surgical Technique Guide should be directed to United Orthopedic Corporation at unitedorthopedic.com/contact

The CE mark is valid only if it is also printed on the product label.

Documents

Device Description Product Overview